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临床试验/NCT06022640
NCT06022640已完成不适用

The Assessment of Educational and Supportive Care to the Depressed Infertile Females Undergo In Vitro Fertilization Procedure by Clinical Pharmacist: Randomized Clinical Trial

Al-Rasheed University College2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
Pregnancy rate

研究概览

简要总结

Infertility affects married adults, and In Vitro Fertilization (IVF) is an Assisted Reproductive Technology (ART) that can be treated. Women undergoing IVF are more likely to experience depression. There is a need to reduce depression by supporting and advising sufferers. The aim of this study is to evaluate pharmacist counseling's impact on pregnancy rates in depressed infertile females during IVF treatment.

详细描述

Infertility affects 10-15% of couples, both men and women, and can cause anxiety, worry, grief, and disappointment. It is a major life experience that can affect all aspects of a couple's life. Preconception counseling is a necessary prerequisite for infertility treatment, as it evaluates the medical, social, genetic, environmental, and occupational factors that influence fertility and pregnancy health. Depression is a common issue among infertile females, and pharmacists play a crucial role in the care of depressed patients.

The etiology of female infertility is unknown, but ovulatory disorders, endometriosis, pelvic adhesions, tubal blockage, other tubal abnormalities, and hyperprolactinemia account for 81% of all cases. Age has a negative impact on fertility, and the prevalence of age-related infertility rises as reproductive years decrease. Treatment for infertility aims to resolve treatable causes and overcome intractable ones. General management principles for infertile couples include determining the cause and treatment, suggesting changes in behavior that increase fertility, stopping smoking, and limiting exposure to harmful substances.

Assisted reproductive technology (ART) is used to treat infertility, which involves fertility therapies involving both eggs and sperm. In vitro fertilization (IVF) is widely recognized as the most effective method of ART. IVF is one of the most successful therapies for infertility, but it sometimes requires multiple attempts at oocyte picking and embryo transfer. It is effective in treating undiagnosed infertility, obstructed or broken fallopian tubes, genetic disorders, women with uterine fibroids, ovulation problems, or early ovarian failure, and women who have had their ovaries surgically removed.

The IVF cycle involves ovarian stimulation, which involves fertility drugs to stimulate egg production and regulate ovulation. Examples of ovarian stimulation regimens include leuprolide acetate, also known as Lupron, which is used in conjunction with birth control pills for the first week. Anti-estrogens like clomiphene citrate, also known as Clomid, are used to manage anovulation by selectively modulating estrogen receptor activity. Follicle-stimulating hormone (FSH) is a medication that stimulates the ovaries, potentially serving as an alternative therapeutic option for women with anovulation who have undergone unsuccessful cycles of anti-estrogens. Human chorionic gonadotropin injections (HCG) are commonly used to induce ultimate maturation, stimulating ovulation when there is at least one fully developed ovarian follicle. The American Society for Reproductive Medicine advises the transfer of a specific quantity of embryos, whether they are in a fresh or frozen state.

Emotional changes in IVF patients are common, with anxiety and depression being more common in infertility patients with psychiatric illness, miscarriage, a longer infertility timeline, and a definitive medical diagnosis. Stress levels increase as therapy becomes more intensive and lasts longer, making IVF patients more stressed than women at the beginning of their infertility examination.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • To be an infertile lady who spent at least one year after marriage failing to get pregnant and who should then undergo the IVF cycle.
  • To be within the reproductive age (18-45 years old); the success rates of IVF tend to decline with increasing age[4].
  • To have the ability to read and understand.
  • Have depression

排除标准

  • Patient with previous failure of I.V.F. procedure.
  • Very obese (BMI > 40)[37].
  • Patient with psychiatric problems (psychiatric hospital admission, addiction, neurological or other progressive disease, and psychiatric drug use).
  • A patient who has a situation that prevents communication (language and hearing problems).

结局指标

主要结局

Pregnancy rate

时间窗: Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment.

The outcome of IVF cycles, as measured by clinical pregnancy rates, was recorded after the intervention

次要结局

  • Depression status(Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment.)
  • Fertility Quality of Life.(Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment.)

研究者

发起方
Al-Rasheed University College
申办方类型
Other
责任方
Sponsor

研究点 (2)

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